2011-07
2015-07-31
2015-07-31
400
NCT02958683
Heart of England NHS Trust
Heart of England NHS Trust
OBSERVATIONAL
Chest Wall Motion Analysis in Disease
Breathing movements, called chest wall motion, are very complex. The investigators are studying how movement of the abdomen, ribs and diaphragm contribute to breathing and how this differs with different diseases in the chest. Breathing movements may help with diagnosis, assessment of severity or assessing the impact of treatments for chest conditions. The investigators are following people who have a chest disease, measuring their chest wall motion and comparing it to their diagnosis and and how their treatment works. Chest wall motion can be measured in different ways at rest and whilst exercising. Small stickers on the chest can be used to reflect infra red light or visible squares of light can be shone onto the chest without using stickers.
Optoelectronic plethysmography (OEP) is based on the analysis during breathing of the trajectories of a series of markers positioned on the thoracic-abdominal surface of the patient. The positions in space of these markers are recorded and processed with mathematical models and algorithms by a computing unit that can accurately measure not only volume variations of the whole thoracic-abdominal wall, but also the variations of the various compartments. This detects, for example, asymmetries in the action of respiratory muscles. The system can accurately measure current volume, vital capacity, respiratory frequency, duration of the phases of inspiration and exhalation, the average inspiration and exhalation flux and the volume variations at the end of exhalation. Structured Light Plethysmography (SLP) also assesses regional chest wall excursion but does not require markers to be placed on the patient. The system uses visible light shone onto the chest wall in a checkerboard pattern and reflected back by the patient's skin or a tight T shirt. Images from 4 Microsoft Kinnect Motion Cameras can be used to create a 3D representation of the patient's torso. This system has been shown to correlate well with chest wall measurements recorded by OEP. These systems are innovative examination instruments, non-invasive, accurate, easy to use and unlike traditional plethysmographic technologies, are not affected by humidity and temperature variations and can easily be used to perform measurements for extended periods of time. They accurately measure the dynamics of the volume variations that occur during breathing in the various sections of the thoracic-abdominal walls (upper, lower and abdominal thoracic area). This data, which is otherwise undetectable, is a useful contribution to the evaluation of patients. We will apply chest wall motion analysis to understanding the physiology of thoracic disease processes as well as assessing potential diagnostic and prognostic (response to treatment) markers that could be used in future clinical practice.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2016-08-05 | N/A | 2019-02-21 |
2016-11-04 | N/A | 2019-02-22 |
2016-11-08 | N/A | 2019-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
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: Pectus excavatum Patients with pectus excavatum (funnel chest) condition undergo chest wall motion analysis | OTHER: Chest wall motion analysis
|
: Pectus carinatum Patients with pectus carinatum (pigeon chest) condition undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Chronic obstructive pulmonary disease Patients affected by COPD undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Diaphragm abnormality Patients with abnormal function or structure of the diaphragm. Including diaphragmatic hernia/rupture and diaphragmatic paralysis undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Healthy control People who do not have any diagnosed thoracic condition and who do not have symptoms/signs suggestive of undiagnosed thoracic disease undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Lung cancer Patients with suspected or confirmed lung malignancy of all histological subtypes undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Pleural disease Patients with pleural thickening and/or pleural effusion, pneumothorax, empyema undergo chest wall motion analysis | OTHER: Chest wall motion analysis
|
: Asthma Patients diagnosed with asthma clinically or upon spirometry undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Cystic fibrosis Patients diagnosed with cystic fibrosis clinically or biochemically undergo chest wall motion analysis | OTHER: Chest wall motion analysis
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: Rib or sternal disease Patients with an abnormality in the chest wall including fractures, osteomyelitis, malignancy of all histological subtypes, chest wall resection/reconstruction undergo chest wall motion analysis | OTHER: Chest wall motion analysis
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Change in volume of each thoracoabdominal compartment during breathing | Measured in litres | Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months) |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Synchrony of chest wall movement | Measured in degrees | Baseline, follow up after normal clinical care up to 3 times (inpatient after surgery, 4-6 weeks, 3-12 months) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
16 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications